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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Non-Implanted
510(k) Number K192302
Device Name Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
Applicant
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Carol S Ming
Correspondent
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Carol S Ming
Regulation Number876.5540
Classification Product Code
MPB  
Subsequent Product Code
NIE  
Date Received08/23/2019
Decision Date 01/17/2020
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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